MAUDE Adverse Event Report: CAREFUSION, INC BD® COMBINED SPINAL EPIDURAL TRAY; ANESTHESIA CONDUCTION KIT

Model Number 405828

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the epidural catheter in the bd® combined spinal epidural tray was blocked/occluded during the injection.The following information was provided by the initial reporter: "we have had several epidural catheters that seem to be occluded, or not allowing smooth injection." "we had a case last week, thought the catheter had clotted so we replaced it (it was a catheter you had actually placed).When we replaced, i ¿played¿ with the old one, and found that 1 hole was obstructed but then was able to flush".

Manufacturer Narrative

H.6.Investigation: one photo sample was received by our quality team for investigation.Upon visual inspection of the sample, it cannot be determined if the tubing was occluded or damaged therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001414074 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h.10.

Event Description

It was reported that the epidural catheter in the bd® combined spinal epidural tray was blocked/occluded during the injection.The following information was provided by the initial reporter: "we have had several epidural catheters that seem to be occluded, or not allowing smooth injection." "we had a case last week, thought the catheter had clotted so we replaced it (it was a catheter you had actually placed).When we replaced, i ¿played¿ with the old one, and found that 1 hole was obstructed but then was able to flush".

• Brand Name: BD® COMBINED SPINAL EPIDURAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12497858
• MDR Text Key: 272251644
• Report Number: 1625685-2021-00063
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 405828
• Device Catalogue Number: 405828
• Device Lot Number: 0001414074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1